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Welcome
Thank you for downloading our ‘Prevention & FMEA’ white paper which will help you to regard
Preventive Action as a useful tool to help assess business risks and not an exercise to keep the
auditor happy.
There is often debate about where corrective action ends, and where preventive action begins.
For instance, if a problem is detected in one process, are the actions taken to avoid possible
problems in other processes truly considered as being preventive actions, or are they simply
part of the corrective actions taken to fix the initial problem?
Don't be “side-tracked” by such arguments – life’s too short. Instead, focus on whether the
actions were effective.
If you want to know more about problem solving and investigative tools, the UK's National
Health Service Improvement Network has a comprehensive tool box
To your success!
Stephanie Keen
info@iso9001help.co.uk
www.iso9001help.co.uk
Your house is on fire. You dial 999 and the Fire Service duly arrives and puts out the
fire. This is Control of Non-conformance (ISO 9001 Para 8.3).
Subsequently, you ban smoking in your home, install smoke detectors and fire
extinguishers so that minor fires can be avoided or at least contained. This is Corrective
Action (ISO 9001 Para 8.5.2).
Fortunately, you had the foresight to buy adequate insurance to cover any losses. This
is Preventive Action (ISO 9001 Para 8.5.3).
ISO 9000:2005 Para 3.6.4 defines Preventive Action as “action to eliminate the cause of a
potential non-conformity or other undesirable potential situation”.
Don't be thrown by the word 'potential'. Physicists tell us that we live in a quantum universe,
every atom is constantly in flux: absolutely anything is possible.
However, because something is possible it does not mean that it is likely. You can only address
the problems (and potential problems) you know about and to try to detect the ones you don't.
Preventive Action & FMEA
What is FMEA?
FMEA (Failure Mode and Effects Analysis) is a team-based activity to assess actual and
potential problems, assign a risk factor and decide a course of action. This method is used in
many industries such as automotive, medical device manufacturing, aerospace, and chemical
processing.
FMEA is not a specific ISO 9001 requirement, however this approach satisfies ISO 9001 Para
8.5.3 Preventive Action.
Overview
Every product or process is subject to different problems or "failure modes" and these potential
failures all have consequences or "effects". Failure mode and effects analysis (FMEA) is way
to:
Identify the potential failures and the associated relative risks in a product or process
Prioritise action plans to reduce those potential failures with the highest relative risk
Track and evaluate the results of those actions
The process for conducting an FMEA is straightforward. First, describe the product/process and
its function/purpose.
Then identify:
Failures: The manner in which a part, assembly, or system could potentially fail to meet
its requirements or fail to function. It is also what you may reject the item for.
Effects: The potential non-conformance stated in the terms of the process or product
performance.
Causes: The potential reasons behind the failure mode, usually stated as an indication
of a specific design or process weakness.
For example:
Trend analysis for process and product characteristics (see ISO 9001:2000 Para 8.4
data analysis). A worsening trend often prompts preventive action
Failure mode and effect analysis for processes and products (this technique is
commonly used by the automotive industry.
Evaluating problems that have occurred in similar circumstances, but in other products,
processes, or other parts of the business, or other organisations - see your trade press
for details.
Planning for both predictable situations (e.g. personnel changes – see also ISO 9001
Para 5.4.2) and for unpredictable situations (e.g. naturally disasters, terrorist threats,
etc.)
TOP TIP: Para 8.5.3 says that preventive actions must in proportion with the effect of the failure.
You have analysed the causes of potential problems (use of cause and effect diagrams
and other quality tools may be appropriate for this). If you want to know more about
these tools, follow this link to the UK's National Health Service quality improvement site
FMEA Method
Who should do it?
FMEA is typically conducted by small team of people, ideally each whom with a slightly different
view of the product or process under consideration. The variety of perspectives that a team can
bring to FMEA is what makes it so powerful.
Preventive Action & FMEA
An individual will not be able to develop as comprehensive and valuable FMEA as a team can
produce. One-man FMEAs are typically done to satisfy customer requirements, and generally
contribute nothing to the business.
While the FMEA process is relatively straightforward it is essential that the target product or
process is well-defined so that the team doesn't go off at a tangent.
FMEA Step-by-Step
These steps can be worked through using Post-It notes, a whiteboard or a spreadsheet so you
may add, subtract and modify ideas as you go along.
This helps simplify the process of analysis by identifying the product/process uses that
fall within the intended function and which fall outside.
This should show the major components or process steps as blocks connected together
by lines that indicate how the components or steps are related. The diagram shows the
logical relationships of components and establishes a structure around which the FMEA
can be developed.
For each failure identified, try to estimate what the ultimate effect will be.
A failure effect is defined as the result of a failure mode on the function of the
product/process as perceived by the customer. They should be described in terms of
what the customer might see or experience should the identified failure mode occur.
Keep in mind the internal as well as the external customer. Examples of failure effects
include:
Death or injury
Malfunction of the product or process
Improper appearance of the product or process
Preventive Action & FMEA
Reduced performance
Minor cosmetic problem
A commonly used scale: 1 represents low effect; 10 indicates very severe with the
failure affecting system operation and safety without warning.
The intention is to help decide whether a failure would be classified as a minor nuisance
or a catastrophic occurrence to the customer.
The potential causes for each failure should be identified and documented. The causes
(not the symptoms) should be listed. Examples of potential causes include:
Corrosion
Contamination
Improper alignment
Excessive delays
Excessive voltage
Current controls are the mechanisms that prevent the cause of the failure mode from
occurring or which detect the failure before it reaches the Customer.
Decide what testing, analysis, monitoring, and other techniques that can or have been
used on the same or similar products/processes to detect failures.
The FMEA should then be updated and plans made to address those failures to
eliminate them from the product/process
Detection is an assessment of the likelihood that the current controls will either, detect
the cause of the failure or the failure itself, thus preventing it from reaching the
Customer. Based on the current controls, consider the likelihood of Detection.
A commonly used scale: 1 indicates that detection is very likely; 10 to indicates that the
problem will almost never be detected.
Address potential failures that have a high RPN. Typically, the top 30% are targeted.
Assign responsibility and target completion dates for the actions. This makes
responsibility clear-cut and helps tracking
13 Follow-up
After these actions have been taken, re-assess the severity, probability and detection
and review the revised RPN's. Are any further actions required?
Not customising the three rating scales with company specific examples so that they
are meaningful to your company.
A design or process expert is either not included on the FMEA team or is allowed to
dominate the team.
Team members have not been properly trained in the use of FMEAs and become
frustrated with the process.
The team gets bogged down with minute details and losing sight of the overall
objective.
Rushing through the generation of potential failure modes, overlooking significant but
obscure failure modes.
Listing practically the same effect for every failure mode and not being specific (for
example "customer will be unhappy").
Stopping once the RPNs are calculated and not acting on the highest risk failures.